Influence of in vitro release methods on assessment of tobramycin ophthalmic ointments.

Abstract

The current investigation was carried out to identify appropriate parameters for measuring the in vitro release of tobramycin (TOB) ophthalmic ointments and to evaluate the feasibility of in vitro release testing methods to assess the product performance. Drug release was assessed using USP dissolution apparatus IV and a modified USP dissolution apparatus I with simulated tear solution (STS) as the dissolution medium. The study variables included temperature, membrane material, source and pore size. The results demonstrated a significant influence of the membrane source and pore size on the release of TOB from the ointments. A dissolution medium temperature of 40°C was found to be appropriate for the release studies. Both of the apparatuses were able to discriminate between the release profiles of ointments with different physicochemical/rheological properties. Maximum release rate of TOB was observed in the first hour which followed a logarithmic time dependent release. The correlation between the release rates/amounts and yield stress of the ointments was observed in both the dissolution apparatuses. These results support a rational approach to guide the in vitro release testing of TOB ophthalmic ointments.